Software as Medical Device

This roadmap describes the journey of software as a medical device from basic research, concept development down to clinical testing and entry to market.

Switch to the progress tracker for this roadmap

D1
Basic Research

Basic research that generates new knowledge, insights, methods or technologies, but has no immediate health & care application.
[TRL 1]

D2
Strategic Research

Research that addresses a class of health & care problems, developing knowledge, insights, methods or technologies that may underpin innovative solutions.
[TRL 1]

D3
Concept Development

Research that draws on existing knowledge, insights, methods or technologies to develop the concept for an innovative solution to a specific health & care problem.
[TRL 2]

D4
Prototype Development & Technical Feasibility

Research that develops the proposed health & care innovation and provides initial evidence for the feasibility of the proposed innovation.
[TRL 3, 4]

T1
Product Development & Healthcare Feasibility

Research that further develops the proposed health & care innovation and provides reproducible evidence for its efficacy and safety in a relevant environment.
[TRL 5, 6]

T2
Product Testing & Proof-of-value

Investigations that evaluate the proposed innovation in a health & care setting, providing actionable evidence of its efficacy, effectiveness and safety in a patient population.
[TRL 7]

T3
Regulatory Approvals & Route-to-market

Activities that finalise the regulatory approvals, and the commercialisation, implementation and scaling-up strategies for the health & care innovation.
[TRL 8]

T4
Product Launch & Real-world Learning

Activities that lead to product launch, and evaluation of the real-world effectiveness and safety of the innovation, to avoid harm and inform future developments.
[TRL 9]

D1: Basic Research

Basic research that generates new knowledge, insights, methods or technologies, but has no immediate health & care application.
[TRL 1]

Developing novel methods and software not targeted at a specific health & care application.

  • R&D1:

    Develop generic methods and technology

  • BM1:

    Understand IP management and contract-related research disclosure agreements

Potential funding sources

UKRI, Wellcome Trust, Leverhulme Trust, Royal Society, Royal Academy of Engineering, Horizon Europe, other charities, companies

Deliverables

  • Generic methods and technology with indicative evidence of performance

D2: Strategic Research

Research that addresses a class of health & care problems, developing knowledge, insights, methods or technologies that may underpin innovative solutions.
[TRL 1]

Developing methods and software to address an area of health & care need.

  • R&D1:

    Develop applied methods and technology based on available health & care data, following good laboratory practice (GLP) principles with accurate and detailed record keeping

  • R&D2:

    Perform scientific literature review on applied methods and technology development based on available health & care data

  • HEST1:

    Identify potential areas of health & care application

  • R1:

    Understand ethical/HRA approvals & research governance requirements (including contracts and sponsorship) for obtaining existing healthcare data

  • BM1:

    Consider IP protection (e.g. patenting); record funding and contracts for IP ownership

Potential funding sources

UKRI, Wellcome Trust, Leverhulme Trust, Royal Society, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, internal translational funding calls, companies

Deliverables

  • Understanding of potential use in healthcare setting

  • Finding / creating indicative evidence from literature or early studies on performance of methods and technology

  • IP protection initiated (if applicable)

D3: Concept Development

Research that draws on existing knowledge, insights, methods or technologies to develop the concept for an innovative solution to a specific health & care problem.
[TRL 2]

Reaching out to stakeholders from STEM, applied health research and clinical practice to provide insights necessary to design and develop an innovative concept for addressing a specific health & care problem.

  • R&D2:

    Record device requirements, prior knowledge and evidence of a valid clinical association to inform device specification

  • R&D3:

    Create software specification and design for development of prototype (consider whether coding language is suitable for end use)

  • R&D4:

    Understand and consider human factors that influence the development of the solution

  • R&D5:

    Understand and consider aspects of responsible innovation that influence the development of the solution (including health equity assessment and strategies for bias mitigation)

  • HEST1:

    Understand current and foreseeable specific health & care need

  • HEST2:

    Understand current and foreseeable clinical guidance relevant to the health & care need being addressed

  • HEST3:

    Understand current and foreseeable clinical workflows relevant to the health & care need being addressed

  • HEST4:

    Draft how the product may be embedded into the current and foreseeable clinical service (e.g. considering clinical workflows and patient pathways) to inform concept development

  • HEST5:

    Draft the outline value proposition and target product profile (including logic diagram development); consider competing solutions (existing or currently under development) which may impact the clinical need, guidance, workflows or pathways

  • HEST6:

    Conduct health economics “desk research” (literature review) and conceptualise a preliminary health economic model to inform concept development; consider current and upcoming competing solutions

  • R1:

    Arrange ethical/HRA approvals for suitable healthcare development data (including sponsorship)

  • R2:

    Formalise intended use (based on HEST2/3); understand both Software as Medical Device (SaMD) regulations and risk classification to inform concept development

  • R3:

    Understand requirements around quality management systems (e.g. version control) and the recording of design decisions, data and activities

  • BM1:

    Consider additional IP protection based on developed concept and freedom to operate; record funding and contracts for IP ownership

  • BM2:

    Identify the market (i.e. who is going to buy it); understand market size to determine if there is a viable market

  • BM3:

    Understand of market share including analysis of competitors

  • HCE1:

    Collect patient and end user feedback of concept

Potential funding sources

UKRI, Wellcome Trust, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, internal translational funding calls, companies

Deliverables

  • Clearly articulated health & care need

  • Solution concept and draft intended use statement

  • Initial value proposition and target product profile

  • Ethical approval for healthcare data to be used for development and testing in the lab

  • Initial summary of market opportunity (including product/market fit)

D4: Prototype Development & Technical Feasibility

Research that develops the proposed health & care innovation and provides initial evidence for the feasibility of the proposed innovation.
[TRL 3, 4]

Exploring technical options, developing a prototype device and demonstrating the technical feasibility of the proposed innovation via pilot studies in the lab. This may be an iterative process that requires testing of multiple different prototypes.

  • R&D3:

    Collate representative healthcare data; develop an initial prototype (according to good machine learning practice (GMLP) for medical device development if applicable)

  • R&D4:

    Address human factors when developing the prototype

  • R&D5:

    Address aspects of responsible innovation when developing the prototype

  • R&D6:

    Test the prototype in the lab to evidence technical feasibility; compare prototype performance to existing solutions

  • HEST4:

    Refine how the product will be embedded into the clinical service

  • HEST5:

    Refine the value proposition and target product profile

  • HEST6:

    Refine the conceptualised health economic model and identify data to collect

  • R2:

    Define the intended use of the SaMD and its target population; determine the correct SaMD categorisation of the solution and understand implications

  • R3:

    Work towards quality management system requirements to ensure accurate audit trail of prototype device development (including design decisions, uses of external plugins/components, etc.); create software in accordance with IEC 62304 (and where applicable ISO/IEC 27001)

  • R4:

    Initialise a technical file (e.g. documented user requirements, software requirements, design decisions, regulatory risk assessments) to be used in the future for clinical investigation approval by relevant regulatory body (e.g. MHRA, EMA, FDA)

  • R5:

    Understand the requirements for regulatory assessment (e.g. UKCA, CE, FDA), for example, with regards to software development standards and clinical investigation standards

  • P&D1:

    Seek industry partners (including service providers, suppliers, manufacturers and distributors - also considering start-up formation); understand the IT infrastructure of the health & care environment (including software and hardware); understand Digital Technology Assessment Criteria (DTAC) requirements

  • BM2:

    Finalise market size analysis to determine if there is a viable market

  • BM3:

    Finalise market share opportunity (including analysis of competitors)

  • BM4:

    Develop a commercial strategy for delivering the device to market (will it be a product or service?)

  • BM5:

    Develop a commercial strategy (for-profit, or not-for-profit (e.g. via a community interest company)) for delivering the device to market including considerations around setting up a spin-out or licensing out the innovation as academic exit strategy

  • BM6:

    Draft an outline business model (consider creating a business canvas)

  • HCE1:

    Create a clinical evaluation plan (CEP) to define the scope and outline the systematic approach of the planned clinical investigation to demonstrate scientific, analytical and clinical validity

Potential funding sources

UKRI, Wellcome Trust, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, Innovate UK, internal translational funding calls, companies

Deliverables

  • Prototype with indicative evidence of performance (demonstrating technical feasibility)

  • Proof-of-concept in the lab

  • Revised value proposition and target product profile

  • Finalised intended use statement

  • Quality management system processes identified and in operation

  • Initial regulatory risk assessment

  • Initial technical file

  • Potential service providers, suppliers, manufacturers and distributors have been identified

  • Revised summary of market opportunity (demonstrating commercial feasibility and competitiveness)

  • Proposed strategy for delivering the innovation to market (including academic exit strategy)

  • Initial outline business model

  • Clinical evaluation plan

T1: Product Development & Healthcare Feasibility

Research that further develops the proposed health & care innovation and provides reproducible evidence for its efficacy and safety in a relevant environment.
[TRL 5, 6]

Refining the prototype, developing the product, and conducting a feasibility investigation to generate evidence of health & care relevance and safety in a realistic but controlled health & care setting. This may be an iterative process that requires testing of multiple different prototypes before committing to the final design.

  • R&D4:

    Refine the prototype addressing human factors and usability

  • R&D5:

    Refine the prototype addressing aspects of responsible innovation when developing the prototype (including health equity requirements and cyber security requirements)

  • R&D6:

    Refine the prototype addressing findings of lab pilot studies

  • R&D7:

    Refine the prototype based on health & care feasibility data and key stakeholder feedback (e.g. patients, end user)

  • R&D8:

    Refine the prototype based on health & care efficacy data and key stakeholder feedback (e.g. patients, end user)

  • R&D9:

    Complete R&D activities including the creation of the Device Master List/Record (detailing all processes required to create the device; to include with the technical file) and freeze the design of the refined product

  • HEST4:

    Refine how the product will be embedded into the clinical workflow / health and care pathway

  • HEST5:

    Refine the value proposition and target product profile

  • HEST6:

    Refine the conceptualised health economic model and health economics data collection

  • R1:

    Arrange Ethical approvals for pilot studies in health & care setting

  • R3:

    Develop device in line with ISO13485 (including QMS) as well as any other applicable standards (e.g. IEC 62304, IEC 82304-1, IEC 81001-5-1, IEC 62366-1, DCB 0129, ISO/IEC 27001), involving industry partners (e.g. manufacturer) as needed

  • R4:

    Refine the technical file (e.g. design decisions, regulatory risk assessments, test methods) for clinical investigation approval

  • R5:

    Start to collect clinical evidence on efficacy and safety for regulatory assessment (e.g. UKCA, CE, FDA) and if affecting clinical outcomes run the study to accepted good clinical practice (GCP) standards (e.g. ISO 14155)

  • P&D1:

    Work with industry partners (including service providers, suppliers, manufacturers and distributors - also considering start-up formation); develop and test the product for integration into health & care environment (including integration into health & care services and IT infrastructure)

  • P&D2:

    Implement a test environment for functional and non-functional testing of the source code (e.g. performance, usability, compatibility, accessibility, security); perform functional and non-functional testing of the product’s source code for verification and validation

  • P&D3:

    Assess Safety, compliance, interoperability, cyber security (ISO/IEC 27001) and usability of the product; review Digital Technology Assessment Criteria (DTAC) requirements

  • P&D4:

    Conduct quality control of refined product to assess whether it meets the specifications and requirements

  • BM4:

    Review commercial strategy for delivering the device to market (considering refinements of the product/service)

  • BM5:

    Review commercial strategy for delivering the device to market (considering refinements of the product/service) as well as the academic exit strategy

  • BM6:

    Refine the business model

  • HCE1:

    Perform health & care risk assessment

  • HCE2:

    Conduct investigation of the product to generate evidence of health & care feasibility

  • HCE3:

    Conduct investigation of the product to generate evidence of health & care efficacy and safety (based on risk classification)

Potential funding sources

UKRI, Wellcome Trust, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, Accelerated Access Collaborative (SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists

Deliverables

  • Final product (frozen development/design)

  • Approvals and access in place for real-world healthcare dataset

  • Revised value proposition and target product profile

  • Conceptual health economic model with preliminary data

  • Ethical approval for pilot studies in health & care setting

  • Development process according to ISO13485

  • Revised technical file

  • Functional and non-functional testing completed

  • Relationships have been established with potential service providers, suppliers, manufacturers and distributors

  • Revised strategy for delivering the innovation to market (including academic exit strategy)

  • Revised outline business model

  • Evidence of utility in a health and care setting

T2: Product Testing & Proof-of-value

Investigations that evaluate the proposed innovation in a health & care setting, providing actionable evidence of its efficacy, effectiveness and safety in a patient population.
[TRL 7]

Embedding the product in a real-world health & care setting and conducting a pivotal study to demonstrate safety and generate evidence of stakeholder value.

  • HEST4:

    Refine how the product will be embedded into the health & care pathway by integrating collected evidence

  • HEST5:

    Refine the value proposition and target product profile by integrating collected evidence

  • HEST6:

    Develop the health economic model/case based on the preliminary modelling and collected evidence

  • R4:

    For any clinical investigations that may affect the outcome of a patient, refine and submit the technical file (e.g. design decisions, test methods, and regulatory risk assessment to standard ISO 14971) for MHRA approval for pivotal clinical investigation of final product (to get exemption for clinical investigation of a non-CE/UKCA marked device)

  • R5:

    Prepare application for regulatory assessment (e.g. UKCA, CE, FDA)

  • BM4:

    Review commercial strategy for delivering the device to market (considering refinements of the product/service)

  • BM5:

    Review commercial strategy for delivering the device to market (considering refinements of the product/service) as well as the academic exit strategy

  • BM6:

    Refine the business model

  • BM7:

    Assess commercial viability to confirm that the development, distribution and maintenance of the software is financially sustainable (including return-on-investment analysis); seek company or venture capitalist funding

  • HCE4:

    Conduct pivotal clinical investigation to confirm efficacy, health & care effectiveness and safety in line with ISO14155; usability study for regulatory purposes (IEC62366) based on final product; write a clinical evaluation report (CER) to summarise the results of the clinical evaluation plan process

  • HCE5:

    Initialise plans for post-market surveillance and clinical follow-up

Potential funding sources

UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, Accelerated Access Collaborative (SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists

Deliverables

  • Revised value proposition and target product profile based on collected evidence

  • Early health economic model

  • Revised technical file (including revised regulatory risk assessment)

  • Partnerships have been formed with key stakeholders (e.g. suppliers, service providers, manufacturers, distributors/customers)

  • Revised strategy for delivering the innovation to market (including academic exit strategy)

  • Revised business model

  • Clinical evaluation report

T3: Regulatory Approvals & Route-to-market

Activities that finalise the regulatory approvals, and the commercialisation, implementation and scaling-up strategies for the health & care innovation.
[TRL 8]

Obtaining regulatory approvals, and finalising the business model and commercial strategy to attract funding for implementation and adoption.

  • HEST4:

    Finalise how the product will be embedded into the health & care pathway by integrating collected evidence

  • HEST5:

    Finalise the value proposition and target product profile

  • HEST6:

    Finalise full health economic analysis

  • HEST7:

    Refine end-user business model / procurement case for the product (including needs assessment, cost-benefit analysis, implementation and adoption strategies)

  • HEST8:

    Consider adoption of the product into policy and/or guidelines as a routine method or approach; prepare proposal for NICE Early Valuation Assessment; prepare for DTAC certification

  • R5:

    Finalise technical file (e.g. design decisions, regulatory risk assessments, clinical evaluation report); submit technical file for regulatory assessment (e.g. UKCA, CE, FDA) or self-declare product (risk class dependent)

  • P&D5:

    Plan scale-up of production (including support and maintenance)

  • P&D6:

    Get Digital Technology Assessment Criteria (DTAC) accreditation (if appropriate)

  • BM6:

    Finalise the full business model

  • BM7:

    Confirm commercial viability of the product; seek company or venture capitalist funding

  • BM8:

    Refine a sales and marketing strategy based on business model

  • HCE5:

    Refine and finalise plan for post-market surveillance and clinical follow-up

Potential funding sources

NIHR, Accelerated Access Collaborative (SBRI Healthcare), Horizon Europe, other charities including condition-specific charities, internal translational funding calls, companies, venture capitalists

Deliverables

  • Finalised value proposition and target product profile

  • Full health economic analysis

  • Finalised technical file (including revised regulatory risk assessment)

  • CE/UKCA marking

  • DTAC accreditation (if appropriate)

  • Full business model

  • Product ready for deployment

  • Sales and marketing plan

  • Post-market surveillance plan

T4: Product Launch & Real-world Learning

Activities that lead to product launch, and evaluation of the real-world effectiveness and safety of the innovation, to avoid harm and inform future developments.
[TRL 9]

Collecting real-world evidence and using it to avoid harm and further refine the technology and its application. This may inform product improvement and may require additional regulatory approval.

  • HEST7:

    Monitor end-user business model / procurement case for the product; ongoing health economic analysis

  • HEST8:

    Obtain NICE Health Technology Evaluation recommendation (if appropriate)

  • R6:

    Collate post-market clinical evidence on safety and performance; update clinical evaluation report regularly and maintain quality management system

  • P&D5:

    Implement scale-up to meet market demand

  • P&D6:

    Launch and distribute product (including strategies for communication and training processes to increase acceptability by end users)

  • BM8:

    Implement the sales and marketing strategy (including customer outreach activities and advertising)

  • HCE5:

    Conduct post-market surveillance and post-market clinical follow-up of the product to collect data on long-term effectiveness, safety, potential adverse effects, and usage of the device

Potential funding sources

NIHR, Accelerated Access Collaborative (SBRI Healthcare), companies, venture capitalists

Deliverables

  • End-user business model / procurement case

  • NICE Health Technology Evaluation recommendation (if appropriate)

  • Initial release version of the product has been manufactured and deployed

  • Updated clinical evaluation report with post-market surveillance and post-market clinical follow-up data